Cleared Abbreviated

K011352 - ROSSMAX SMARTINFLATE CARDIOPRO, MODEL 1000I AND MODEL 3000I BLOOD PRESSURE MONITORS

K011352 is an FDA 510(k) clearance for ROSSMAX SMARTINFLATE CARDIOPRO, manufactured by Rossmax International , Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Abbreviated 510(k) pathway after a 78-day FDA review.

K011352 · Rossmax International , Ltd. · Cardiovascular device
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Jul 2001
Decision
78d
Days
Class 2
Risk

K011352 is an FDA 510(k) clearance for the ROSSMAX SMARTINFLATE CARDIOPRO, MODEL 1000I AND MODEL 3000I BLOOD PRESSURE MO.... Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Rossmax International , Ltd. (Taipei, TW). The FDA issued a Cleared decision on July 20, 2001 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Rossmax International , Ltd. devices

FDA 510(k) Submission Details - K011352

510(k) Number K011352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2001
Decision Date July 20, 2001
Days to Decision 78 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 125d · This submission: 78d
Pathway characteristics
Standards-based clearance path.

DXN Device Classification - Class 2, Special Controls

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXN System, Measurement, Blood-pressure, Non-invasive

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